A new era for clinical trials in Europe
2022 marks a new era for clinical trials in the EU as the European Commission’s Clinical Trials Regulation comes into effect. But what does it mean for sites, sponsors and the public?
The long-awaited EU Clinical Trials Regulation (CTR) came into effect last week on 31 January 2022. The CTR codifies existing guidance with regard to clinical trial regulation, sets it on a statutory setting, and adds new definitions and submission requirements. The CTR is intended to improve the submission and review processes for clinical trials via a centralized portal the Clinical Trials Information System (CTIS).
CTR seeks to harmonize the registration, assessment and supervision of clinical trials across all member states via the CTIS. The CTIS, set up and maintained by the EMA, will host the EU Portal and Database for all EU clinical trials.
There will be a three-year transition period whereby:
Until 31 January 2023, Sponsors can still choose whether to submit an initial clinical trial application in line with the Directive or via CTIS.
From 31 January 2023, submission of initial clinical trial applications via CTIS becomes mandatory, but existing trials that were approved on the basis of the Directive can continue to be governed by the Directive until 31 January 2025.
As well as confirming the full implementation of CTR the EMA, EC and HMA announced a new initiative this month, called Accelerating Clinical Trials in the EU (“ACT EU”).
- Boost research and innovation in the EU
- Increase efficiency, particularly for multi-country trials within the EU, by reducing duplication
- Improved collaboration and information sharing
- Greater transparency in how clinical trials are conducted
- Promotes the highest standards of safety for patient participants
- Boost patient recruitment by allowing sponsors to easily expand trials across member states
CROMOS PHARMA AND THE EU CTR
It is likely that adaption to the CTR will be a learning curve for all involved in clinical research but once successfully in operation will deliver many advantages to Sponsors and assessors.
Cromos Pharma’s team can assist in smoothing the transition to the EU CTR by advising on protocol language and necessary new processes.